Tokyo, Sept. 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059111) titled 'A study to measure the glycemic index (GI)' on Sept. 17.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Agro Ludens Inc.

Condition: Condition - Healthy Japanese Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the effect of consuming the test food on the GI. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Single ingestion

Test food: Comeat(R) (fermented rice product, 128.9 g)

Sato No Gohan (150 g)

Test food: Add 100 mL of hot water to the test food, wait 5 minutes, and consume within 10 minutes. If consuming within 10 minutes is difficult, consume within 15 minutes. Carbohydrate load: Consume within 10 minutes. If consuming within 10 minutes is difficult, consume within 15 minutes. Approximately 150 cc of hot water or water may be taken with it.

*The intervention sequence is: Carbohydrate load, followed by Carbohydrate load, followed by Test food.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Individuals aged 20 or more and less than 50

4. Healthy individuals

5. Individuals whose body mass index (BMI) is less than 30 kg/m2 Key exclusion criteria - 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"

5. Individuals who have food allergies and/or food intolerances. Particularly, individuals who have lactose intolerance.

6. Individuals who have abnormal glucose tolerance

7. Individuals who take medications known to affect glucose tolerance

8. Individuals who have used insulin for diabetes or taken antihyperglycemic drugs

9. Individuals who have been hospitalized for treatment or surgery within the last three months

10. Individuals who plan to have surgery within two weeks after this study

11. Individuals who have or are undergoing medical treatment for diseases which influence digestion and absorption of nutrients

12. Individuals who are taking steroids, protease inhibitors, or antipsychotics

13. Individuals who are taking or using medicines (including herbal medicines) or supplements

14. Individuals who are allergic to medicines or foods related to the test product

15. Individuals who are pregnant, lactating, or planning to become pregnant during this study

16. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study

17. Individuals who are judged as ineligible to participate in this study by the physician Target Size - 10

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 08 Month 06 Day Date of IRB - 2025 Year 08 Month 06 Day Anticipated trial start date - 2025 Year 09 Month 17 Day Last follow-up date - 2025 Year 11 Month 12 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067574

Disclaimer: Curated by HT Syndication.